- midazolam hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 01502/0059 .
Midazolam 1 mg/ml solution for injection / infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Midazolam 1 mg/ml solution for injection / infusion
Midazolam 2 mg/ml solution for injection / infusion
Midazolam 5 mg/ml solution for injection / infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Midazolam is and what it is used for
2. What you need to know before you use Midazolam
3. How to use Midazolam
4. Possible side effects
5. How to store Midazolam
6. Contents of the pack and other information
1. WHAT MIDAZOLAM IS AND WHAT IT IS USED FOR
Midazolam belongs to a group of medicines called ‘benzodiazepines’. Midazolam works quickly to make you feel sleepy or to put you to sleep. It also makes you calm and relaxes your muscles.
Midazolam is used in adults:
Midazolam is also used in adults and children:
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MIDAZOLAM
Do not use Midazolam:
You must not use Midazolam if any of the above applies to you. If you are not sure, talk to your doctor or nurse before you use this medicine.
Warnings and precautions
Talk to your doctor or nurse before using Midazolam:
If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you use Midazolam.
Other medicines and Midazolam
Concomitant use of Midazolam and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Midazolam together with opioids the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Midazolam can affect the way some other medicines work. Also some other medicines can affect the way Midazolam works.
In particular, tell your doctor or nurse if you are taking any of the following medicines:
If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given Midazolam.
Midazolam with alcohol
Do not drink alcohol if you have been given Midazolam. This is because it may make you feel very sleepy and cause problems with your breathing.
Pregnancy and breast-feeding
Talk to your doctor before you are given Midazolam if you are pregnant or think you may be pregnant. Your doctor will decide if this medicine is suitable for you.
After you have been given Midazolam, do not breast-feed for 24 hours. This is because Midazolam may pass into your breast milk.
Driving and using machines
After having Midazolam, do not drive or use tools or machines until your doctor says you can.
This is because Midazolam may make you feel sleepy or forgetful. It may also affect your concentration and co-ordination. This may affect you being able to drive or use tools and machines. After your treatment, you must be taken home by an adult who can look after you.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Midazolam contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
3. HOW TO USE MIDAZOLAM
Midazolam will be given to you by a doctor or nurse. It will be given to you in a place that has the equipment needed to monitor you and to treat any side effects. This might be a hospital, clinic or doctor’s surgery. In particular, your breathing, heart and circulation will be monitored.
Midazolam is not recommended for use in infants and babies under 6 months of age. However, if the doctor feels that it is necessary, it can be given to an infant or baby under 6 months who is in intensive care.
How Midazolam will be given to you
You will be given Midazolam in one of the following ways:
How much Midazolam will be given to you
The dose of Midazolam varies from one patient to another. The doctor will work out how much to give you. It depends on your age, weight and general health. It also depends on what you need the medicine for, how you respond to treatment, and whether you are going to be given other medicines at the same time.
After being given Midazolam
After your treatment, you must be taken home by an adult who is able to look after you. This is because Midazolam may make you sleepy or forgetful. It may also affect your concentration and co-ordination.
If you are given Midazolam for a long time, such as in intensive care, your body may start to get used to the medicine. This means it may not work as well.
If you use more Midazolam than you should
Your medicine will be given to you by a doctor or nurse. This means it is unlikely that you will be given too much. However, if you are given too much by mistake, you may notice the following:
Long term use of Midazolam for sedation in intensive care
If you are given Midazolam for a long time, the following may happen:
If you stop using Midazolam
If you are given Midazolam for a long time, such as in intensive care, you may get withdrawal symptoms when you stop being given the medicine. These include:
Your doctor will lower your dose gradually. This will help to stop withdrawal symptoms from happening to you.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported but their frequency is not known and cannot be estimated from the available data.
Stop having Midazolam and see a doctor straight away if you notice any of the following side effects. They can be life-threatening and you may need urgent medical treatment:
Life-threatening side effects are more likely in adults over 60 years, and in people who already have breathing or heart problems. These side effects are also more likely if the injection is given too fast or at a high dose.
Other possible side effects
Nervous system and mental problems
Heart and circulation
Mouth, stomach and gut
Reporting of side effects
If you get any side effects, talk to your doctor or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MIDAZOLAM
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Midazolam contains
What Midazolam looks like and contents of the pack
Midazolam comes in a colourless glass ampoule/vial (small bottle). It is a clear, colourless, liquid (solution for injection/infusion).
The following pack sizes are available for Midazolam 1 mg/ml solution for injection / infusion:
The following pack sizes are available for Midazolam 2 mg/ml solution for injection / infusion:
The following pack sizes are available for Midazolam 5 mg/ml solution for injection / infusion:
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml, solution for injection / infusion
DE Midazolam-hameln 1 mg/ml, 2 mg/ml, 5 mg/ml Injektions- /Infusionslösung
DK Midazolam ”Hameln”
FI Midazolam Hameln 1 mg/ml, 5 mg/ml injektio-/infuusioneste, liuos
NL Midazolam 1 mg/ml, 2mg/ml, 5 mg/ml Hameln, oplossing voor injectie / infusie
SE Midazolam Hameln 1 mg/ml, 5 mg/ml injektions-/infusionsvätska, lösning
This leaflet was last revised in 01.2019.